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Completed

NCT Number: NCT00451958

A Long-term Extension Study Evaluating a One-Month Dosing Regimen of Degarelix in Prostate Cancer Requiring Androgen Ablation Therapy

Participants who completed the FE200486 CS21 study (NCT00295750) could enter the FE200486 CS21A study. The study continued until all non-discontinued participants had received treatment for at least 5 years.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site, Kentville, Nova Scotia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion/Exclusion Criteria:

  • Patients with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.
  • Signed informed consent
  • The patients must have completed the FE 200486 CS21 Study.

Treatment and study plan

Degarelix 80 mg / Degarelix 80 mg

Drug

Other names: Firmagon

Degarelix 160 mg / Degarelix 160 mg

Drug

Other names: Firmagon

Leuprolide 7.5 mg / Degarelix 80 mg

Drug

Other names: Firmagon, Lupron

Leuprolide 7.5 mg / Degarelix 160 mg

Drug

Other names: Firmagon, Lupron

Primary outcomes

  1. Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight

    Time frame: Up to 4 years of treatment

    This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline (from main CS21 study, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A.

  2. Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables

    Time frame: Up to 4 years of treatment

    This outcome measure included incidence of markedly abnormal changes in safety laboratory values. The table presents the number of participants with normal baseline (from main CS21 trial, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A. Only the laboratory variables that had at least five percentages of participants in either group with abnormal value are presented, more variables were included in the study. ULN=Upper limit of normal.

Secondary outcomes

  1. Percentage of Participants With no Prostate-specific Antigen (PSA) Progression

    Time frame: Until all participants have received at least 5 years of treatment and at a frequency of every 3 months

    PSA progression was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir (obtained in either CS21, NCT00295750, or CS21A). The figures below present the percentage of participants with no PSA progression at each of the selected time points (there were more time points in the study) along with corresponding 95% confidence intervals (CI).

  2. Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards

    Time frame: Until all participants have received at least 5 years of treatment and at a frequency of every 6 months

    The results below present the percentage of participants of having testosterone <=0.5 ng/mL at each of the selected time points (there were more time points in the study) from Day 28 in CS21 (NCT00295750) until the end of the CS21A study.

    In all treatment groups approximately 3% per year of the participants had at least one testosterone >0.5 ng/mL during the study.

  3. Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56

    Time frame: From time of switch to Day 56

  4. Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56

    Time frame: From time of switch to Day 56

  5. Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56

    Time frame: From time of switch to Day 56

  6. Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56

    Time frame: From time of switch to Day 56

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

An Open-Label, Multi-Centre, Extension Study, Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Patients With Prostate Cancer Requiring Androgen Ablation Therapy

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Mar 26, 2007
Registry last updated
Mar 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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